ADVANCED CLINICAL Looking for Medical Safety Specialist III at Princeton, NJ Full Time

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team to work remotely as a Medical Safety Specialist III. The Medical Safety Specialist III role will apply medical/clinical experience and product knowledge to multifunctional teams (i.e., Clinical, Quality, Risk Management, Complaint Management and Medical Affairs) to deliver product safety guidance to NPI and sustaining teams throughout the entire product lifecycle. The MSS participates in all activities related to the safety and performance of any post-market product or investigational product in development. Candidates utilize their knowledge of evolving global regulations and provide safety input to all internal and external customers and stakeholders inclusive of leading or contributing to the review and composition of clinical/regulatory reports and correspondences with global regulatory authorities. Risk documentation development and utilization for safety signal detection and reporting. Safety management responsibilities required for clinical study program oversight inclusive of adverse event adjudication, MedDRA coding, and management of escalation of events to Complaints and reporting to ethics boards per their requirements. Additional responsibilities include Medical Device Technical File support for EUMDR remediation activities as needed. Development of departmental policies and procedures. 

Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Create, edit, review, and/or approve all labeling i.e., understand the device and device use, patient population/intended user, indications for use, alternative therapies and treatments, contraindications, clinical benefits, and the potential complications and required warnings and precautions required to be included in the labeling.
• Adjudicate adverse events related to all products to ensure accuracy, integrity, and completeness of safety information.
• Consistency code adverse events via MedDRA requirements.
• Participate in safety signal detection activities to allow signal identification, evaluation, validation, and management for marketed products including individual and aggregate data analyses, interpretation of safety signals and trends, documentation and communication of safety risks in collaboration with key internal and external stakeholders.
• Assist internal and external stakeholders, including Regulatory, and Quality Assurance customers and regulatory bodies in evidence-based and historical data regarding medical safety.
• Assist in the post-market review of potential safety concerns identified through multiple departments, including Quality, Clinical, Regulatory, and Product Quality.
• Provide Medical Assessments for new or unusual safety matters that involve critical, death or legal issues. Investigate the relationship to the device; and determine potential escalation.
• Participate in Product Safety Review Board; biweekly review of potential safety issues identified through post-market monitoring. Discuss particulars of the Medical Assessments
• Collaborate with appropriate investigational personnel, clinical, and/or Complaint or Quality assurance personnel regarding returned product analysis.
• Participate in clinical protocol development for inclusion of safety requirements.
• Draft Safety Management Plans for clinical studies.
• Quality partner, providing medical input in the development and update of risk documentation (BRA, FMEAs), field actions, and draft Health Impact Assessments for inclusion into risk documentation and or Health Hazard Evaluations for field safety actions and communications.
• Investigate specific events by contacting internal resources, field employees, HCP customers, and international staff as appropriate.
• Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
• Collaborate with other team members and work under the direction of the Medical Safety Director.
• Maintain knowledge of relevant regulations for classifying and reporting medical device and drug adverse events.
• Ability to review and summarize medical literature.
• Maintain team relationships within the organization (domestic and international) through effective and timely communication.
• Participate in team meetings to provide updates to all assigned activities and address safety- related concerns.
• Develop Pharmacovigilance training materials and conduct training presentations.
• Ability to identify and respond to critical issues and problems for immediate corrective action resolution.

EXPERIENCE

• Medical degree with a minimum of 5 years relevant experience in a clinical setting involving patient care to fully understand disease states and diverse treatment options, expected outcomes, and complications of treatments.
• 5+ years of preferable experience in the medical device industry.
• Patient care experience
• Experience within the Neurosurgical side
• Medical Affairs/Safety or Clinical Management experience with the ability to perform patient assessments.
• Ability to follow national and international regulations and reporting requirements for adverse events, and medical device complaints.
• Experience analyzing medical/scientific data and demonstrating knowledge of principles of device development, pharmacology, clinical trial methodology and design, assessment of drug/device risks and benefits, and safety assessments for both marketed devices and those in development.

EDUCATION

• Medical Degree Required

To be a best-fit your strengths must include:

• Proficient in Microsoft Office Suite (Outlook, Word, Excel) and TrackWise adverse events reporting software.
• Working knowledge of FDA guidance for clinical safety surveillance
• Strong attention to detail.
• Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge.
• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and ability to provide sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

Equal Employment Opportunity
It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.